{"id":3929,"date":"2025-06-17T16:48:33","date_gmt":"2025-06-17T13:48:33","guid":{"rendered":"https:\/\/dmdwarrior.com\/?p=3929"},"modified":"2025-06-17T16:48:34","modified_gmt":"2025-06-17T13:48:34","slug":"capricor-therapeutics-announces-bmd-orphan-drug-designation-and-dmd-program-regulatory-development-for-deramiocel-cap-1002","status":"publish","type":"post","link":"https:\/\/dmdwarrior.com\/es\/capricor-therapeutics-announces-bmd-orphan-drug-designation-and-dmd-program-regulatory-development-for-deramiocel-cap-1002\/","title":{"rendered":"Capricor Therapeutics anuncia la designaci\u00f3n de medicamento hu\u00e9rfano BMD y el desarrollo regulatorio del programa DMD para Deramiocel (CAP-1002)"},"content":{"rendered":"<p class=\"wp-block-paragraph\">Capricor Therapeutics, empresa biotecnol\u00f3gica que desarrolla terapias transformadoras basadas en c\u00e9lulas y exosomas para el tratamiento de enfermedades raras, anunci\u00f3 hoy que la Administraci\u00f3n de Alimentos y Medicamentos de EE. UU. (FDA) (FDA) ha otorgado la designaci\u00f3n de medicamento hu\u00e9rfano a Deramiocel (CAP-1002), su principal candidato a terapia celular, para el posible tratamiento de la distrofia muscular de Becker (DMB). Esta designaci\u00f3n refuerza la posici\u00f3n estrat\u00e9gica de Capricor, ya que desarrolla una plataforma totalmente integrada dirigida a las complicaciones card\u00edacas y esquel\u00e9ticas de la distrofia muscular y ampl\u00eda el potencial comercial de su principal activo. <a href=\"https:\/\/dmdwarrior.com\/es\/what-is-deramiocel\/\">\u00bfQu\u00e9 es Deramiocel? \u00bfQu\u00e9 hace CAP-1002?<\/a> \u2013<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Capricor Therapeutics avanza con pasos seguros<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>US FDA otorga la designaci\u00f3n de medicamento hu\u00e9rfano a Deramiocel para el tratamiento de la distrofia muscular de Becker, ampliando el enfoque de Capricor en enfermedades neuromusculares.<\/strong><\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Capricor sigue en camino para la fecha del 31 de agosto de 2025, seg\u00fan la Ley de Tarifas para Usuarios de Medicamentos Recetados (PDUFA) para Deramiocel en Distrofia Muscular de Duchenne luego de la exitosa Inspecci\u00f3n Previa a la Licencia FDA<\/strong><\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">La distrofia muscular de Becker, al igual que la distrofia muscular de Duchenne (DMD), es un trastorno neuromuscular progresivo ligado al cromosoma X que provoca un deterioro significativo del m\u00fasculo esquel\u00e9tico y card\u00edaco con el tiempo. Deramiocel se est\u00e1 desarrollando para abordar ambos aspectos de la patolog\u00eda de la enfermedad, incluida la miocardiopat\u00eda, un contribuyente principal a la morbilidad y la mortalidad en pacientes con DMB y DMD.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>La Solicitud de Licencia Biol\u00f3gica (BLA) de Capricor para Deramiocel en DMD contin\u00faa bajo revisi\u00f3n prioritaria, con una fecha de acci\u00f3n objetivo de PDUFA del 31 de agosto de 2025.<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>M\u00e1s informaci\u00f3n<\/strong>: <a href=\"https:\/\/dmdwarrior.com\/es\/capricor-therapeutics-deramiocel-mid-cycle-review-meeting-with-fda\/\">Capricor Therapeutics anuncia la finalizaci\u00f3n de la reuni\u00f3n de revisi\u00f3n<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>Capricor Therapeutics, a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to Deramiocel (CAP-1002), the company\u2019s lead cell therapy candidate, for the potential treatment of Becker Muscular Dystrophy (BMD). This designation strengthens Capricor\u2019s strategic [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":3931,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[281],"tags":[361,90,86,87,89,85,117,362,88],"class_list":["post-3929","post","type-post","status-publish","format-standard","has-post-thumbnail","category-press-releases","tag-bmd","tag-cap-1002","tag-capricor","tag-capricor-therapeutics","tag-cardiomyopathy","tag-deramiocel","tag-dmd","tag-dmd-cardiomyopathy","tag-fda"],"_links":{"self":[{"href":"https:\/\/dmdwarrior.com\/es\/wp-json\/wp\/v2\/posts\/3929","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/dmdwarrior.com\/es\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/dmdwarrior.com\/es\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/es\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/es\/wp-json\/wp\/v2\/comments?post=3929"}],"version-history":[{"count":0,"href":"https:\/\/dmdwarrior.com\/es\/wp-json\/wp\/v2\/posts\/3929\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/es\/wp-json\/wp\/v2\/media\/3931"}],"wp:attachment":[{"href":"https:\/\/dmdwarrior.com\/es\/wp-json\/wp\/v2\/media?parent=3929"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dmdwarrior.com\/es\/wp-json\/wp\/v2\/categories?post=3929"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dmdwarrior.com\/es\/wp-json\/wp\/v2\/tags?post=3929"}],"curies":[{"name":"gracias","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}